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St. Jude Medical Announced European CE Mark Approval of Assura

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St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced European CE Mark approval of the Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura family of devices, featuring Shockguard™ technology has three new algorithms that help protect patients against inappropriate shocks while providing the highest amount of delivered energy. These improvements are projected to reduce inappropriate therapy by 74 percent, allowing for more effective therapy1. Products currently available in Europe include the Quadra Assura™ CRT-D, Unify Assura™ CRT-D and Fortify Assura™ ICD.

ICDs are implantable cardiac devices that treat abnormally fast, potentially lethal heart rhythms that can lead to sudden cardiac death (SCD) if left untreated. A CRT-D device resynchronizes the beat of the heart's lower chambers, which often beat out of sync in heart failure patients. A CRT-D also provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure.

Posted-In: News FDA


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